Trial Outcomes & Findings for A Phase II Study of Intra-arterial Chemotherapy With Cisplatin and Mitomycin-C in Patients With Hepatocellular Carcinoma (NCT NCT00183885)

Last Updated: 2025-10-30

Results Overview

A modified Response Evaluation Criteria In Solid Tumors (RECIST) will be used. The modification to RECIST is that although all lesions will be followed, only the treated lesions will be included in the assessment of response. Additionally, all lesions will be evaluated according to the following criteria: Presence of arterial enhancement: Yes or No. Complete Response (CR) = Absence of enhancing tumor areas, reflecting complete tissue necrosis. Partial Response (PR) = A decrease \> 50% of enhanced areas, reflecting partial tissue necrosis. Stable Disease (SD) = A tumor response between PR and PD. Progression (PD) = An increase \> 25% in the size of \> 1 measurable lesion(s) or the appearance of new lesions in the treated area (ie, specific segment or lobe of liver targeted by the intra-arterial infusion).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

76 participants

Primary outcome timeframe

Up to 2 years

Results posted on

2025-10-30

Participant Flow

Recruitment for this study opened in October 2004 and closed in February 2012. All subjects were seen and treated in the medical clinics at the University of Southern California.

Participant milestones

Participant milestones
Measure	Cisplatin + Mitomycin-C CDDP 60mg/m2 + Mitomycin-C 12mg/m2 mitomycin-c, cisplatin: Intra-arterial cisplatin 60 mg/m2 and mitomycin-C 12 mg/m2 every 8 weeks
Overall Study STARTED	76
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Reasons for withdrawal
Measure	Cisplatin + Mitomycin-C CDDP 60mg/m2 + Mitomycin-C 12mg/m2 mitomycin-c, cisplatin: Intra-arterial cisplatin 60 mg/m2 and mitomycin-C 12 mg/m2 every 8 weeks
Overall Study Adverse Event	11
Overall Study Death	1
Overall Study Lost to Follow-up	3
Overall Study Physician Decision	6
Overall Study Withdrawal by Subject	5
Overall Study Switched to alternative treatment	8
Overall Study Treatment delayed too long	4
Overall Study Developed second malignancy	1

Baseline Characteristics

A Phase II Study of Intra-arterial Chemotherapy With Cisplatin and Mitomycin-C in Patients With Hepatocellular Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cisplatin + Mitomycin-C n=76 Participants CDDP 60mg/m2 + Mitomycin-C 12mg/m2 mitomycin-c, cisplatin: Intra-arterial cisplatin 60 mg/m2 and mitomycin-C 12 mg/m2 every 8 weeks
Age, Continuous	61 Years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	23 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	29 Participants n=5 Participants
Region of Enrollment United States	76 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Population: Patients with measurable tumor who complete one cycle, or who terminate treatment for reasons of toxicity, or who progress prior to completion of one cycle, will be included in analysis of tumor response.

Outcome measures

Outcome measures
Measure	Cisplatin + Mitomycin-C n=76 Participants CDDP 60mg/m2 + Mitomycin-C 12mg/m2 mitomycin-c, cisplatin: Intra-arterial cisplatin 60 mg/m2 and mitomycin-C 12 mg/m2 every 8 weeks
Tumor Response CR	0 Participants
Tumor Response PR	7 Participants
Tumor Response SD	47 Participants
Tumor Response PD	11 Participants
Tumor Response Inevaluable for Response	11 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Population: All eligible patients who begin treatment are included in the analysis.

Toxicity will be assessed according to CTCAE version 3.0

Outcome measures

Outcome measures
Measure	Cisplatin + Mitomycin-C n=76 Participants CDDP 60mg/m2 + Mitomycin-C 12mg/m2 mitomycin-c, cisplatin: Intra-arterial cisplatin 60 mg/m2 and mitomycin-C 12 mg/m2 every 8 weeks
Number of Participants With Grade 3 or Higher Toxicity	75 Participants

Adverse Events

Cisplatin + Mitomycin-C

Serious events: 51 serious events

Other events: 75 other events

Deaths: 44 deaths

Serious adverse events

Serious adverse events
Measure	Cisplatin + Mitomycin-C n=76 participants at risk CDDP 60mg/m2 + Mitomycin-C 12mg/m2 mitomycin-c, cisplatin: Intra-arterial cisplatin 60 mg/m2 and mitomycin-C 12 mg/m2 every 8 weeks
Blood and lymphatic system disorders Hemoglobin	3.9% 3/76 • Number of events 3 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Blood and lymphatic system disorders Leukocytes	5.3% 4/76 • Number of events 6 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	25.0% 19/76 • Number of events 27 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Blood and lymphatic system disorders Platelets	35.5% 27/76 • Number of events 48 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
General disorders Fatigue (asthenia, lethargy, malaise)	11.8% 9/76 • Number of events 10 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
General disorders Anorexia	6.6% 5/76 • Number of events 5 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Constipation	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Dehydration	3.9% 3/76 • Number of events 4 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Diarrhea	2.6% 2/76 • Number of events 3 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Nausea	9.2% 7/76 • Number of events 10 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Vomiting	7.9% 6/76 • Number of events 6 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Esophageal hemorrhage	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Hepatobiliary disorders Liver dysfunction/failure (clinical)	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
General disorders Edema limb	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Investigations Alanine aminotransferase increased	10.5% 8/76 • Number of events 12 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Investigations Aspartate aminotransferase increased	10.5% 8/76 • Number of events 10 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Investigations Alkaline phosphatase increased	1.3% 1/76 • Number of events 2 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Investigations Blood bilirubin increased	6.6% 5/76 • Number of events 7 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Investigations Creatinine increased	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Metabolism and nutrition disorders Hyperglycemia	6.6% 5/76 • Number of events 6 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Metabolism and nutrition disorders Hyperkalemia	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Metabolism and nutrition disorders Hyponatremia	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Psychiatric disorders Confusion	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Abdominal pain	10.5% 8/76 • Number of events 8 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Renal and urinary disorders Pain (bladder)	1.3% 1/76 • Number of events 2 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.3% 1/76 • Number of events 2 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Renal and urinary disorders Renal failure	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.

Other adverse events

Other adverse events
Measure	Cisplatin + Mitomycin-C n=76 participants at risk CDDP 60mg/m2 + Mitomycin-C 12mg/m2 mitomycin-c, cisplatin: Intra-arterial cisplatin 60 mg/m2 and mitomycin-C 12 mg/m2 every 8 weeks
Ear and labyrinth disorders Hearing impaired	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Ear and labyrinth disorders Tinnitus	3.9% 3/76 • Number of events 4 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Blood and lymphatic system disorders Hemoglobin decreased	78.9% 60/76 • Number of events 119 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Blood and lymphatic system disorders Leukocytes (total WBC) decreased	3.9% 3/76 • Number of events 5 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	22.4% 17/76 • Number of events 47 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Blood and lymphatic system disorders Platelets decreased	51.3% 39/76 • Number of events 96 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Cardiac disorders Hypertension	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
General disorders Fatigue (asthenia, lethargy, malaise)	69.7% 53/76 • Number of events 97 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	7.9% 6/76 • Number of events 8 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
General disorders Insomnia	2.6% 2/76 • Number of events 3 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Investigations Weight loss	1.3% 1/76 • Number of events 2 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Skin and subcutaneous tissue disorders Alopecia	6.6% 5/76 • Number of events 5 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
General disorders Injection site reaction/extravasation changes	7.9% 6/76 • Number of events 8 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Skin and subcutaneous tissue disorders Pruritus/itching	3.9% 3/76 • Number of events 3 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Skin and subcutaneous tissue disorders Rash/desquamation	5.3% 4/76 • Number of events 4 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Skin and subcutaneous tissue disorders Rash: hand-foot skin reaction	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Anorexia	55.3% 42/76 • Number of events 66 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Ascites (non-malignant)	6.6% 5/76 • Number of events 6 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Constipation	7.9% 6/76 • Number of events 8 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Dehydration	2.6% 2/76 • Number of events 3 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Diarrhea	18.4% 14/76 • Number of events 20 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Dry mouth/salivary gland (xerostomia)	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Dysphagia (difficulty swallowing)	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Heartburn/dyspepsia	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Mucositis/stomatitis (functional/symptomatic) (Oral cavity)	2.6% 2/76 • Number of events 2 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Nausea	50.0% 38/76 • Number of events 59 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Taste alteration (dysgeusia)	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Vomiting	18.4% 14/76 • Number of events 19 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Nervous system disorders Hemorrhage, CNS	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Skin and subcutaneous tissue disorders Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)	2.6% 2/76 • Number of events 3 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils (Urinary tract NOS)	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Infections and infestations Infection with unknown ANC (Urinary tract NOS)	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
General disorders Edema: limb	30.3% 23/76 • Number of events 37 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
General disorders Edema: trunk/genital	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
General disorders Edema: viscera	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Metabolism and nutrition disorders ALT (SGPT) increased	43.4% 33/76 • Number of events 58 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Metabolism and nutrition disorders AST (SGOT) increased	50.0% 38/76 • Number of events 65 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	19.7% 15/76 • Number of events 22 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Metabolism and nutrition disorders Alkaline phosphatase increased	48.7% 37/76 • Number of events 59 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Metabolism and nutrition disorders Bilirubin (hyperbilirubinemia)	55.3% 42/76 • Number of events 70 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	2.6% 2/76 • Number of events 2 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Metabolism and nutrition disorders Creatinine increased	9.2% 7/76 • Number of events 10 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	19.7% 15/76 • Number of events 23 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Metabolism and nutrition disorders Lipase	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Metabolism and nutrition disorders Magnesium, serum-low (hypomagnesemia)	3.9% 3/76 • Number of events 4 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Metabolism and nutrition disorders Potassium, serum-high (hyperkalemia)	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Metabolism and nutrition disorders Potassium, serum-low (hypokalemia)	5.3% 4/76 • Number of events 5 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Metabolism and nutrition disorders Sodium, serum-low (hyponatremia)	6.6% 5/76 • Number of events 5 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Nervous system disorders Confusion	5.3% 4/76 • Number of events 4 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Nervous system disorders Dizziness	22.4% 17/76 • Number of events 21 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Nervous system disorders Encephalopathy	1.3% 1/76 • Number of events 2 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Nervous system disorders Memory impairment	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Nervous system disorders Mental status	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Nervous system disorders Mood alteration (Anxiety)	3.9% 3/76 • Number of events 4 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Nervous system disorders Neuropathy: sensory	3.9% 3/76 • Number of events 4 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Eye disorders Dry eye syndrome	1.3% 1/76 • Number of events 2 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Eye disorders Vision-blurred vision	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Gastrointestinal disorders Pain (Abdomen NOS)	30.3% 23/76 • Number of events 45 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Musculoskeletal and connective tissue disorders Pain (Back)	2.6% 2/76 • Number of events 4 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Musculoskeletal and connective tissue disorders Pain (Extremity-limb)	2.6% 2/76 • Number of events 3 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Nervous system disorders Pain (Head/headache)	5.3% 4/76 • Number of events 4 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Musculoskeletal and connective tissue disorders Pain (Joint)	2.6% 2/76 • Number of events 2 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Respiratory, thoracic and mediastinal disorders Pain (Throat/pharynx/larynx)	1.3% 1/76 • Number of events 2 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
General disorders Pain	2.6% 2/76 • Number of events 2 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Respiratory, thoracic and mediastinal disorders Cough	7.9% 6/76 • Number of events 9 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	9.2% 7/76 • Number of events 12 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Respiratory, thoracic and mediastinal disorders Hiccoughs (hiccups, singultus)	1.3% 1/76 • Number of events 2 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Renal and urinary disorders Cystitis	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Renal and urinary disorders Renal failure	2.6% 2/76 • Number of events 2 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Renal and urinary disorders Urinary frequency/urgency	2.6% 2/76 • Number of events 3 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
Renal and urinary disorders Urinary retention (including neurogenic bladder)	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.
General disorders Flu-like syndrome	1.3% 1/76 • Number of events 1 • Up to 1 year Adverse events are assessed during regularly scheduled follow up.

Additional Information

Victoria Soto

USC/Norris Comprehensive Cancer Center

Phone: (323) 865-0451

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place